Sonnet BioTherapeutics Inc (SONN)

[mick]

$SONN COULD IT BE DIS, up to $40mil.+30% royalty to Sonnet BioTherapeutics Signs Letter Of Intent For Potential Licensing Of Neuropathies Asset To
New Life Therapeutics; Co. To Receive $500K Payment At Signing
And Up To $40M
In Milestones And 30% Royalty On Commercial Sales
7:36 am ET August 4, 2020 (Benzinga) Print
Potential Collaboration in Diabetic Peripheral Neuropathy and Chemotherapy-Induced Peripheral Neuropathy for ASEAN Region


500,000 Non-Refundable Payment to Sonnet on Signing of Letter of Intent
Potential for up to $40 Million in Milestone Payments and 30% Royalty on Commercial Sales


PRINCETON, NJ / ACCESSWIRE / August 4, 2020 / Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"),

a biopharmaceutical company developing innovative targeted biologic drugs, announced today that it has
executed a letter of intent to negotiate an agreement to license its SON-081 and SON-080 assets,

both low-dose formulations of Interleukin 6 (IL-6), for diabetic peripheral neuropathy (DPN) and chemotherapy-induced peripheral

neuropathy (CIPN) to New Life Therapeutics Pte. Ltd. ("New Life") of Singapore.

The licensed territory would include the ASEAN countries of Singapore, Malaysia, Indonesia, Thailand, The Philippines, Cambodia, Brunei, Vietnam, Myanmar and Lao PDR.

The transaction is subject to execution of a definitive agreement to be negotiated between Sonnet and New Life.

Sonnet received a $500,000 non-refundable payment upon execution of the letter of intent from New Life.

The letter of intent outlines an agreement that could total to Sonnet up to $40 million in milestone payments and a royalty of 30% on commercial sales.

Pankaj Mohan, Ph.D., Founder and CEO of Sonnet commented,
"We are excited about the opportunity to partner with New Life to advance our neuropathy assets, especially in diabetic neuropathy.

The potential agreement would not only afford Sonnet development reach into territories with compelling commercial market dynamics,

but will also provide access to the future clinical data for enhancing additional potential partnering in other regions.

Most importantly, I am hopeful that this asset could benefit patients suffering from debilitating neuropathy conditions."

"New Life was created to address critical unmet medical needs in the ASEAN Region in neuropathies,
said Rakesh Aggarwal, CEO of New Life Therapeutics.

"With the explosion of diabetes in this part of the world,
we are excited for the potential to advance SON-081 which could help

diabetic patients recover from the debilitating effects of peripheral diabetic neuropathies,

subject to successful clinical trials and regulatory approval in the Territory.

This is an important first step as we join forces with Singapore and other ASEAN countries to fight the war on diabetes."

Aggarwal added, "We also look forward to the SON-080 opportunity in CIPN, an equally debilitating disease for cancer patients,
representing another unmet medical need.

This asset could potentially provide relief to patients battling
chronic pain, loss of sensation and various motor neuron conditions."

Data from various animal models of neuropathy have demonstrated
the potential of low dose IL-6 as a disease modifier.

Low dose IL-6 treatment demonstrated neurorestorative properties that allowed nerve regrowth,
reinstatement of physiological nerve conductance and restoration of nerve fiber density,

which consequentially reduced pain and aberrant sensations in animals suffering from neuropathy.

In addition, safety monitoring of previous clinical trials in thrombocytopenia that had
enrolled more than 200 cancer patients undergoing chemotherapy
concluded that low-dose IL-6 was generally
safe and well tolerated.

SON-081 is an identical formulation of the same low-dose IL-6, SON-080,

in development for chemotherapy-induced peripheral neuropathy,

where low dose IL-6 is believed to work through a similar mechanism
of action for neuroprotection, nerve growth and pain reduction.

Upon execution of a definitive agreement,
New Life Therapeutics will be responsible for conducting a Phase Ib/IIa pilot scale efficacy study with SON-081 in DPN,

expected to initiate during the first half of 2021.

A pilot scale efficacy study with SON-080 in CIPN will be conducted by Sonnet
and is also expected to be initiated during the first half of 2021.

Gael Hedou, Ph.D., COO of Sonnet BioTherapeutics C.H. S.A. and
one of the early developers of SON-081 stated:

"I have worked on the IL-6 program for the treatment of neuropathies
for several years,
and this potential partnership with
New Life
is an exciting step forward toward bringing this critically needed treatment to
patients and to demonstrate the therapeutic potential of low dose IL-6."

Dr. Hedou further commented,
"the low levels of IL-6 that are naturally released by the muscles
upon exercise is a key mediator of the beneficial effects of sport, including nerve health.

This ability to release IL-6 is often hindered in diabetic patients and, furthermore,
the intensity of exercise needed to release therapeutic levels of
IL-6 is not generally possible in the daily routine of these patients.

Low dose IL-6 intermittently administered to DPN patients reaching physiologically active levels,

has the potential to alleviate patient's condition by regrowing
nerves and ultimately by normalizing sensations that are affected by neuropathic disease."

About Sonnet BioTherapeutics Holdings, Inc.

Founded in 2011, Sonnet BioTherapeutics is an oncology-focused biotechnology company with a proprietary platform for innovating biologic drugs of single or bispecific action.

Known as FHAB™ (Fully Human Albumin Binding), the technology utilizes
a fully human single chain antibody fragment (scFv) that binds to and "hitch-hikes" on human serum albumin (HSA) for transport to target tissues.

FHAB™ is the foundation of a modular, plug-and-play construct for potentiating a range of large molecule therapeutic classes, including cytokines, peptides, antibodies and vaccines.

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